As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy
Job Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy.
You will design and maintain the quality system, conduct audits and inspections, manage risks and CAPAs, and enable change processes and training to influence internal stakeholders and suppliers.
Joining AstraZeneca offers a vibrant environment that encourages new ideas and collaboration, with a commitment to science and continuous research investment to improve patient lives.
Matching Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP regulations and readiness for audits and inspections with high autonomy.
Skills & Requirements
Must-have
GcP/BcP quality governance
audit and inspection management
risk management and CAPA
GxP system validation
document control and SOP management
training development and delivery
stakeholder and supplier management
Nice-to-have
data integrity culture ambassador
advanced Excel for KPI monitoring
collaborative and innovative environment
Key Requirements
Bachelor's degree in Pharmacy, Nursing, Biomedicine, Medicine or related
Solid experience in GcP/BcP quality and clinical research
Experience in audits, inspections and compliance
Proficiency in GxP system validation and document governance
Advanced English proficiency
Experience in deviation investigations and CAPA management